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United States · US · US:55111-257_7eaaea2d-4068-4a22-c7f5-c4ac01d418a1

ziprasidone

Orange BookUNIISPLATC N05AE04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeN05AE04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    5511125701
    100 CAPSULE in 1 BOTTLE (55111-257-01)
  • ndc11
    5511125705
    500 CAPSULE in 1 BOTTLE (55111-257-05)
  • ndc11
    5511125730
    30 CAPSULE in 1 BOTTLE (55111-257-30)
  • ndc11
    5511125760
    60 CAPSULE in 1 BOTTLE (55111-257-60)
  • ndc11
    5511125778
    10 BLISTER PACK in 1 CARTON (55111-257-78) / 10 CAPSULE in 1 BLISTER PACK
  • ndc11
    5511125781
    3 BLISTER PACK in 1 CARTON (55111-257-81) / 10 CAPSULE in 1 BLISTER PACK
  • ndc11
    5511125790
    90 CAPSULE in 1 BOTTLE (55111-257-90)

Annotations

UNII (FDA Substance ID)
216X081ORU
ZIPRASIDONE HYDROCHLORIDE
RxCUI 284925
Orange Book
A077565
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "216X081ORU",
    "rxcui": "284925",
    "inchikey": "ZCBZSCBNOOIHFP-UHFFFAOYSA-N",
    "display_name": "ZIPRASIDONE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7e7261d7-4902-4bb5-a268-6c358890f963": {
      "match": "brand_token",
      "title": "ZIPRASIDONE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "18",
      "published_date": "2026-05-25"
    }
  },
  "productid": "55111-257_7eaaea2d-4068-4a22-c7f5-c4ac01d418a1",
  "productndc": "55111-257",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077565",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Mar 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Mar 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 60MG BASE",
        "product_no": "003",
        "approval_date": "Mar 2, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Mar 2, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZIPRASIDONE HYDROCHLORIDE",
  "proprietary_name": "ziprasidone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077565",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ziprasidone",
  "start_marketing_date": "20120302",
  "active_numerator_strength": "40"
}

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